Back-up Section Leader - Manufacturing

Assists Supervisor and provides daily leadership to employees in the Manufacturing department to ensure safety and quality, maximizing productivity and efficiency while fostering a positive work environment. Plans and communicates daily production needs within the team. Leads manufacturing teams on all assigned job duties, communicating overtime needs, training of new hires, and helping R&D with new processes as Subject Matter Expert. Keeps the supervisor informed of all issues that occur on the shift.

Job Responsibilities:

Assigns qualified personnel as required to meet weekly production schedule including overtime scheduling as needed. Ensures personnel are properly trained and qualified before assigning tasks. Perform daily review of batch documentation for accuracy and completeness. At the end of the batch reviews all batch documentation for accuracy and completeness prior to submitting batch for review. Ensures Operators monitor and document the critical process parameters during the manufacturing process. Investigates process problems, notifies Supervisors, and takes appropriate corrective actions. Performs batch processing steps in accordance with Batch Record manufacturing instructions and current labor standards in order to safely and efficiently manufacture a quality product. Verifies the correctness of all raw materials against the appropriate issuance documents to ensure that the correct materials are used during the manufacturing process. Prints the required in-process labels for manufacturing processes in SAP. Assembles, disassembles, and cleans equipment used for manufacturing in accordance with the applicable GMP procedure to ensure proper operation and cleanliness of the equipment. Works with Quality Assurance and Engineering to ensure the manufacturing process meets quality specifications. Collaborates with Supervisor to ensure that the Manufacturing DLM boards are updated timely and reflect current information. Monitors production schedules, troubleshoots and solves problems. Supervisor of all process-related problems so that appropriate action can be taken. Complies with and enforces GMP dress code standards in order to minimize cross contamination, holding personnel directly accountable for compliance. Ensures housekeeping standards are followed and area is maintained during shift. Contacts engineering support teams as needed to address issues. Follows all departmental and company safety policies in order to prevent injury to self and others. Conducts training of new employees, new positions, processes, and retrains as necessary. Backfills associates in the processing rooms as needed. Trains and audits production employees to ensure current approved SOP's are followed. Supports and promotes all Environmental, Health & Safety initiatives to ensure compliance with corporate and other regulations. Performs other duties in order to meet department's production schedule or to comply with cGMPs. Works as a member of the team to achieve all outcomes. Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements. Performs all work in support of our corporate values: Innovate, Evolve and Excel. Ensures area housekeeping / 5s initiatives are sustained, and all other relevant duties as assigned. J ob Requiremen ts Education High school diploma or general education degree (GED). Experience 10+ years experience in a fast-paced lean Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing) in a GMP environment required. Transdermal Manufacturing/ Packaging experience preferred. Demonstrate career progression within Aveva with a minimum of 3 years experience as a Back-up Section Leader, or equivalent related experience. Knowledge, Skills and Abilities Demonstrates thorough leadership, coaching skills, manufacturing expertise, safety measures knowledge, time management, organizational skills, and the ability to motivate workers. Understands, adheres to, practices Current Good Manufacturing Practices (cGMPs) and to observe safety, environmental, and security policies and procedures during the performance of all assigned responsibilities. Computer knowledge (e.g. JDE, Web Navigation, Email, MS Word and MS Excel). Ability to read English and comprehend documents such as policies, Standard Operating Procedures, batch records and cleaning procedures. Ability to write in English, and complete batch record documentation. Ability to speak English effectively. Must be able to use basic mathematical calculations in multi-level/complex formulas using whole numbers, common fractions, and decimals, following rounding and significant figure rules. Ability to apply common sense understanding to carry out detailed written and oral instructions. Ability to apply problem solving technics to address problems involving variables in standardized situations. Ability to gather data/facts and assists with GMP investigations.